Преждевременный разрыв плодных оболочек (НРНО) встречается п... Инструкция
Показания к применению
AmniSure ROM — экспресс-тест для качественного иммунохромато-графического определения амниотической жидкости во влагалищных выделениях беременной женщины vitro. Тест предназначен для использования специалистами в области здравоохранения в качестве средства для установления разрыва плодных оболочек у беременных женщин.
Инструкция
Состав
Тестовый набор AmniSure ROM содержит следующие компоненты.
1) инструкция по применению; 2) тест-полоска AmniSure ROM в пакете из фольги с поглотителем влаги; 3) стерильные полиэфирные влагалищные тампоны; 4) пластиковая пробирка с растворителем. которая содержит 0.9 % NaCI, 0,01 % Triton Х-100. 0.05 % NaNз.
Описание
Преждевременный разрыв плодных оболочек (НРНО) встречается приблизительно в 10 % беременностей и является одной из важнейших терапевтических проблем в современной акушерской практике. Ведение женщин с ПРПО и ПРПО-НБ (ПРПО при недоношенной беременности, до 37-й недели гестации) требует больших затрат и остается серьезной перинатальной проблемой, так как лечащему врачу необходимо находить компромисс между продолжением беременности и риском инфицирования.
Подтекание амниотической жидкости может оказаться незамеченным, так как она бесцветна и не имеет запаха, ее легко перепутать с другими жидкостями (например, с мочой, влагалищным отделяемым, спермой и т.д). Важность диагностики РПО обусловлена необходимостью своевременного акушерского вмешательства. Тест AmniSure® быстро и точно определяет наличие белка ПАМГ-1, который в высокой концентрации содержится в амниотической жидкости. ПАМГ-1 практически отсутствует у пациенток без РПО.
С ПРПО при доношенном сроке связаны серьезные последствия для новорожденного, такие как преждевременные роды, респираторный дистресс-синдром, выпадение пуповины, отслойка плаценты и инфицирование.1 ПРПО-НБ встречается в 20-40 % случаев ПРПО и ассоциируется с 20-50 % преждевременных родов, инфекционной заболеваемости матери и плода, гипоплазии легких плода, выпадения пуповины, деформации развития плода и послеродового эндометрита. Эти последствия значительно увеличивают материнскую и перинатальную заболеваемость и смертность.
Тест-набор AmniSure ROM является автономной системой для быстрой и точной диагностики ПРО, необходимой для принятия соответствующих акушерских мер в случае разрыва. Кроме того, точная диагностика ПРО позволяет избежать нежелательных вмешательств таких как родовозбуждение или госпитализация.
Показания к применению
AmniSure ROM — экспресс-тест для качественного иммунохромато-графического определения амниотической жидкости во влагалищных выделениях беременной женщины vitro. Тест предназначен для использования специалистами в области здравоохранения в качестве средства для установления разрыва плодных оболочек у беременных женщин.
Способ применения и дозы
ПРИНЦИП ПРОВЕДЕНИЯ ТЕСТА
В тесте AmmSure ROM используется принцип иммумохроматографического обнаружения человеческого плацентарного альфа-микроглобулина-1 (ПАМГ-1 PAMG-1) амниотической жидкости Тест содержит высокочувствительные моноклональные антитела которые позволяют выявить даже минимальное количество ПАМГ-1 в шеечно-влагалищных выделениях после разрыва анодных оболочек. ПАМГ-1 был выбран в качестве маркера разрыва плодных оболочек по причине его высокого содержания в амниотической жидкости, низкого содержания в крови и чрезвычайно низкого фонового уровня е шеечно-влагалищных выделениях при неповрежденных оболочках. Для минимизации частоты ложноотрицательных результатов в тесте используется комбинация нескольких моноклональных антител, которая обеспечивает порог чувствительности теста AmniSure ROM на оптимально низком уровне 5 нг/мл. Максимальная фоновая концентрация ПАМГ-1 в шеечно-влагалищных выделениях немного ниже, чем порог чувствительности теста AmniSure ROM. Это позволяет минимизировать ложноположительные и ложно-отрицательные результаты и повысить точность теста до 98 % . Образец шеечно-влагалищных выделений, собранный с помощью вагинального тампона, помещается для экстракции в пробирку с растворителем. Для обнаружения ПАМГ-1 в пробирку погружается тест-полоска (устройство для латерального проточного иммуноанализа). Результат оценивается визуально по наличию одной или двух линий на тестовой области полоски.
Тест АмниШур (AmniSure® ROM Test) обеспечивает более 99% точности диагностики, независимо от степени разрыва плодных оболочек. Диагностику можно провести самостоятельно. Тест Амнишур по своей легкости применения напоминает тест на беременность, поэтому его можно комфортно поставить и дома .
Особые указания
ПРЕДУПРЕЖДЕНИЯ И МЕРЫ ПРЕДОСТОРОЖНОСТИ-Соблюдайте меры предосторожности во время сбора, обработки и утилизации тестовых образцов.-Не используйте поврежденные компоненты теста.-Использованные тест-наборы, представляют биологическую опасность.-Не используйте после даты истечения срока годности, напечатанного на этикетке.-Не используйте компоненты тест-набора повторно.-Не сгибайте и не сворачивайте тест-полоску или пакет из ал юм и и иевой фольги с тест-полоской внутри.ХРАНЕНИЕ И СТАБИЛЬНОСТЬ-Храните набор в сухом месте при температуре 4-25 НЕ ЗАМОРАЖИВАТЬ.-При хранении в пакете из фольги при рекомендуемой температуре тест остается стабильным вплоть до даты истечения срока годности, указанной на коробке.-Используйте тест AmniSure ROM в течение четырех часов после извлечения тест-полоски из пакета.
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